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Azithromycin for Injection USP 500mg Azithromycin for Injection USP 500mg Azithromycin for Injection USP 500mg Azithromycin for Injection USP 500mg Azithromycin for Injection USP 500mg Azithromycin for Injection USP 500mg Azithromycin for Injection USP 500mg Azithromycin for Injection USP 500mg Azithromycin for Injection USP 500mg Azithromycin for Injection USP 500mg

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Azithromycin for Injection USP 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Azithromycin for Injection USP 500mg
a) Each vial contains:
Azithromycin USP
Eq to Azithromycin (Anhydrous)………500mg
Excipients………………………………………q.s.
b) This pack is also contains:
Sterile Water for Injection USP……… 5ml

THERAPEUTIC INDICATIONS:

Azithromycin injection is used to treat bacterial infections in many different parts of the body. It is also used to prevent Mycobacterium avium complex (MAC) disease in patients infected with the human immunodeficiency virus (HIV). Azithromycin belongs to the class of drugs known as macrolide antibiotics.

DIRECTION OF USE:

Constitute with 100mg/ml with 4.8ml of Sterile Water for Injection USP.
When reconstituted this product maintains its potency for 24 hours at room temperature.
For appropriate diluents and storage recommendations, refer to prescribing information.

CAUTION & WARNING:

CAUTION: The injection should not be used It contains visible particulate matter after reconstitution.
Must be further diluted before use.
Warning: To be sold by retail with the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F)
Keep all medicines out of reach of children.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Dosage: As directed by the Physician.

Azithromycin for Injection USP 500mg Technical Specification:

Product Name:Azithromycin for Injection USP
Brand Name:Generic
Strength:500mg
Dosage Form:Lyophilized Powder for Injection (Sterile, Nonpyrogenic)
Packing:1 Vial + WFI Tray
Route of Administration:For IV Infusion use
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antibacterial, Anti-Infectives, Antibiotic(macrolide)
Indication: Azithromycin injection is used to treat bacterial infections in many different parts of the body. It is also used to prevent Mycobacterium avium complex (MAC) disease in patients infected with the human immunodeficiency virus (HIV). Azithromycin belongs to the class of drugs known as macrolide antibiotics.
Storage:Store at 20°C to 25°C (68°F to 77°F)

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Azithromycin for Injection USP 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Azithromycin for Injection USP 500mg
    a)Each vial contains:
    Azithromycin USP
    Eq to Azithromycin (Anhydrous)………500mg
    Excipients………………………………………q.s.b) This pack is also contains:
    Sterile Water for Injection USP……… 5ml

THERAPEUTIC INDICATIONS:

Azithromycin injection is used to treat bacterial infections in many different parts of the body. It is also used to prevent Mycobacterium avium complex (MAC) disease in patients infected with the human immunodeficiency virus (HIV). Azithromycin belongs to the class of drugs known as macrolide antibiotics.

DIRECTION OF USE:

Constitute with 100mg/ml with 4.8ml of Sterile Water for Injection USP.

When reconstituted this product maintains its potency for 24 hours at room temperature.

For appropriate diluents and storage recommendations, refer to prescribing information.

CAUTION & Warning:

CAUTION: The injection should not be used It contains visible particulate matter after reconstitution.

Must be further diluted before use.

Warning: To be sold by retail with the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F)

Keep all medicines out of reach of children.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Dosage: As directed by the Physician.